Fractional Flow Reserve (FFR) Versus Instant Wave-Free Ratio (iFR)

Completed

• Conditions: Coronary Artery Disease; Plaque, Atherosclerotic

• Registration Number: NCT01559493
• Lead Sponsor: NHS National Waiting Times Centre Board

Brief Summary

Comparison of Fractional Flow Reserve versus instant Wave-Free Ratio for assessment of coronary artery stenosis severity in routine practice

* To compare FFR to iFR in arbitrary consecutive patients referred for percutaneous coronary intervention (PCI).

* To investigate the influence of hyperemia on iFR.

* To test reproducibility of iFR and FFR.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Study First Submitted: 2012-02-14
• Status Verified: 2012-03
• Study First Submitted QC: 2012-03-19
• Last Update Submitted: 2012-03-19
• Study First Posted: 2012-03-21
• Last Update Posted: 2012-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• all consecutive patients undergoing FFR assessment for standard clinical indications.

Exclusion Criteria

• prior CABG
• extremely tortuous, calcified lesions
• coronary artery occlusion
• acute MI within 5 days

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of Fractional Flow Reserve vs. instant Wave-Free Ratio for assessment of coronary artery stenosis severity in routine practice	30 days	In this prospective, multicenter, international investigation, all consecutive patients in 5 centers, referred for PCI will be included. FFR will be submitted for one vessel in each patient - this will be the first vessel in which the FFR is performed. Measurements will be performed in duplicate. iFR will be calculated for all lesions for which an FFR measurement is submitted. In addition, iFR and FFR will be compared retrospectively in 1000 patients who had FFR measurements in the recent past

Secondary Outcome Measures

Name	Time	Method
iFR at rest vs iFr during hyperemia	30 days	iFR is said to be independent of hyperemia. Accordingly a secondary outcome of this study will be a paired comparison of iFR at rest vs iFr with adenosine induced hyperemia.
Repeatability of iFr and FFR	30 days	To test repeatability of iFR and FFR

Trial Locations

Locations (5)

University Hospital Brno; 🇨🇿 Brno, Czech Republic

Stanford University; 🇺🇸 Stanford, California, United States

Cardiovascular Center Aalst; 🇧🇪 Aalst, Belgium

Stockholm South Hospital; 🇸🇪 Stockholm, Sweden

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Netherlands